Apo-Nilotinib

Nilotinib

• Brand(s): Tasigna
• Dosage Form/Strength: 150 mg, 200 mg capsule

For the treatment of patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Note: Ministry will only fund any TWO of the oral Tyrosine Kinase inhibitors (TKIs)* used for chronic phase CML per patient in a lifetime. (*TKIs: imatinib, nilotinib, or dasatinib)
If the patient develops grade 3 or 4 toxicity on one of the above TKI’s within 3 months of initiating therapy, access to a 3rd oral TKI will be funded for that patient.

Approved dose: 300 mg twice daily but not exceeding 800 mg/day

Duration of Approval: 1 Year

For the treatment of patients with accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented intolerance¹ or resistance² to imatinib therapy.

¹Intolerance to imatinib at any dose occurs where the Patient has experienced persistent grade 3 or grade 4 toxicity requiring discontinuation of imatinib therapy; or

²Imatinib resistance occurs where the Patient has primary or acquired resistance to imatinib at doses of at least 600mg/day or via a mutational analysis report.

Exclusion Criteria – Patients with the following exclusion criteria will not be funded:

• blast phase CML;
• for Ph+ acute lymphocytic leukemia (ALL);
• combination treatment with any two or more oral TKIS’s (imatinib, nilotinib, or dasatinib) will not be funded
• For accelerated phase CML, nilotinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to dasatinib.

Approved dosage: Up to 800 mg/day but doses above 800 mg per day will not be considered

Renewal Criteria:
Renewals are considered for patients who experience hematologic and/or cytogenic response to therapy, is expected to continue to benefit from therapy with Tasigna.

Duration of Approval: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests